A Phase I Study of Hepatic Arterial Infusion of Escalating Dose Melphalan With Venous Filtration for Metastatic Unresectable Cancers of the Liver
- Determine the dose-limiting toxicity and maximum tolerated dose of hepatic arterial
infusion with melphalan in patients with unresectable liver cancer.
- Determine the regional and systemic toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients undergo percutaneous hepatic arterial infusion, using a double balloon catheter in
the inferior vena cava to isolate circulation to the liver, with melphalan over 30 minutes
on day 1. Treatment may be repeated when all toxic effects are grade 2 or less. Patients
undergo staging at 4 weeks after completion of the second treatment. Patients may receive 2
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional
patients are treated with melphalan at the recommended dose.
Patients are followed every 3 months for 2 years and then every 4 months for 1 year.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Primary Purpose: Treatment
H. Richard Alexander, MD, FACS
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|